Is Inhaled Insulin Delivery Still A Possibility? Why Has It Been A Commercial Failure?
September 24, 2009
The commercial failure of Exubera® (Pfizer, New York, NY), the first inhaled insulin product to come to market, led other companies like as Eli Lilly-Alkermes to halt studies of similar drug delivery in development intended to contend for a share of the lucrative diabetes market. Does this signal defeat for efforts to discharge insulin via the lungs? The science and pecuniary standing behind the Lilly-Alkermes decision to break off trials of the AIR® inhaled insulin product are explored in a special supplement to Diabetes Technology & Therapeutics, a peer-reviewed diary published by Mary Ann Liebert, Inc. The continuation is available eager online athttp:// www.liebertpub.com/dia
The supplement presents the data on AIR inhaled insulin that has been made profitable by Eli Lilly (Indianapolis, IN) and Alkermes (Cambridge, MA), co-developers of the drug. Eight articles describe various protocols in which the effectiveness and safety of AIR were compared to traditional insulin injections in patients with type 1 or type 2 diabetes. These studies represent noninferiority trials, in that AIR was evaluated for its possible to be at minutest for the reason that safe and effective considered in the state of subcutaneous (SC) insulin across a range of parameters.
Satish K. Garg, MD, Professor of Medicine and Pediatrics at the University of Colorado Denver, and Editor-in-Chief of Diabetes Technology & Therapeutics, and colleagues report the results of a 2-year Phase 3 trial conducted in 385 patients, in each article entitled, “Two-Year Efficacy and Safety of AIR Inhaled Insulin in Patients by Type 1 Diabetes: An Open-Label Randomized Controlled Trial.” The study found AIR to be inferior to SC insulin (in a noninferiority clinical criterion design) in its ability to maintain optimal blood glucose levels over time, based on measurements of glycosylated hemoglobin (HbA1c).
Similarly, Angel L. Comulada, MD, FACE, Instituto de Endocrinología, Diabetes & Metabolismo, Toa Baja, Puerto Rico, and coworkers demonstrated inferiority of AIR in their study of 500 patients through type 1 diabetes over 6 months. They fame their findings in the article “Efficacy and Safety of AIR Inhaled Insulin Compared to Insulin Lispro in Patients by Type 1 Diabetes Mellitus in a 6-Month, Randomized, Noninferiority Trial.”
“The question now leavings whether this route of delivering insulin has been exhausted or if it at rest remainder to be explored,” produce Satish Garg, MD and William Kelly, BS from the University of Colorado Denver in the Editorial “Insulin Delivery via Lungs - Is It Still Possible?” MannKind Corporation recently filed a New Drug Application by the FDA for Technosphere® Insulin. It offers faster storm of agency with lower postprandial blood glucose excursions especially in the first two hours and is moment neutral, according to the Editorial.
Source:
Julia Chapman
Mary Ann Liebert, Inc./Genetic Engineering News
Full Testing Recommended For Medicinal Products Susceptible To ‘Dose Dumping’
September 24, 2009
Controlled set free pills and capsules that become visible a tendency in the standard laboratory test near “dose dumping” - releasing their medicine in a faster and potentially full of risk habits in patients who have consumed alcohol - should be withheld from the market until proven safe with testing in people. That’s the close of a retrace of existing studies in the September-October issue of ACS’ Molecular Pharmaceutics, a bi-monthly journal.
In the article, Hans Lennernäs analyzed the gastrointestinal factors that may contribute to dose dumping when a vulnerable formulation interacts with alcohol present in the stomach. However, these factors are highly variable and depend on individual tippling behavior, whether food is propitious in the relish, and other circumstances. That makes it “within a little impossible” to predict whether a patient will actual feeling any overdose as a be the effect of dose dumping.
Lennernäs thus concludes that which time laboratory testing of a product indicates that the drug will be released more quickly than intended, the product also should subsist pure in humans, or it should have existence re-formulated. Indeed, Lennernäsession believes that lab testing upper a two hour period in a range of alcohol strengths is some “absolute minimum standard” in screening for dose dumping because products with a enigma in the lab may also be dangerous to patients. Lennernäs cites as an example a formulation of the misery medication hydromorphone, what one. was removed from the U.S. market whereas testing revealed that spirits of wine intake caused the risk of overdose. He noted, still, that there is generally a generic oxycodone product on the market in the European Union which will “most that may be liked” lead to dose dumping in patients.
ARTICLE: “Ethanol-Drug Absorption Interaction: Potential for a Significant Effect on the Plasma Pharmacokinetics of Ethanol Vulnerable Formulations”
Source:
Michael Woods
American Chemical Society
View drug information on Oxycodone and Aspirin.
Experts: Social Media Pose a Compliance Risk
September 23, 2009
Experts: Social Media Pose a Compliance Risk
Use of internet-based friendly media similar as Facebook and Twitter can pose compliance risks for drug companies, experts agree. “It’session not the media but the message — and regulatory guidelines are for the reason that unclear for the agencies taken in the character of for the industry,” Mark DeWyngaert, managing director of the Huron Consulting Group, said at the Food and Drug Law Institute’session 21st annual Advertising & Promotion Conference.
BioMarin Initiates Phase 2 Clinical Study Of PEG-PAL In PKU
September 23, 2009
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that the first patient has initiated treatment in the Phase 2 clinical thought of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of phenylketonuria (PKU). Initial top-line results are expected in mid-2010.
“We remain optimistic on this program and believe that, if approved, PEG-PAL may offer a significant benefit for many PKU patients, especially those who do not respond adequately to Kuvan,” said Hank Fuchs, M.D., Chief Medical Officer of BioMarin. “In our view, the flexible delineate of the Phase 2 protocol provides multiple opportunities to arrive at an optimal dose and dosing oftenness that is ordinary in at least in a sub-segment of the PKU population. We are encouraged by the results of the Phase 1 investigate, that showed a sound blood Phe bring to the same level reduction thwart all patients in the fifth battalions at a dose of 0.1mg/kg, no serious adverse events, and reactions as expected with a protein of this nature.
The Phase 2 clinical trial is an open-label, multi-center study to be conducted in up to 35 patients in a succession of dose-escalating cohorts from 0.001 mg/kg. The primary treatment period of eight one time weekly injections at a fixed dose devise be followed by eight weeks of dose and commonness optimization and an extension period where doses can have being increased up to 2.0 mg/kg/week.
The preparatory objective is to evaluate the effect of PEG-PAL on blood Phe concentrations in subjects with PKU. The secondary objectives are to evaluate the safety and tolerability, immune answer and steady state pharmacokinetics of subcutaneous injections of multiple disagreeable lot levels of PEG-PAL.
About PEG-PAL
PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) is an investigational enzyme substitution therapy with a view to the treatment of PKU. Pharmacology studies conducted in the PKU mouse design demonstrated that weekly subcutaneous administrations of PEG-PAL resulted in a significant and stable decrease of plasma phenylalanine. BioMarin estimates that PEG-PAL could be a possible treatment preference for a significant portion of the PKU number of people.
About BioMarin
BioMarin develops and commercializes innovative biopharmaceuticals for momentous diseases and medical conditions. The company’s produce portfolio comprises three approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by the agency of BioMarin; Aldurazyme(R) (laronidase) on this account that mucopolysaccharidosis I (MPS I), a product that BioMarin developed through a 50/50 divide take the liberty through Genzyme Corporation; and Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in association with Merck Serono, a es trangement of Merck KGaA of Darmstadt, Germany. Other performance candidates embody PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), what one. is commonly in Phase II clinical development for the management of PKU and GALNS (N-acetylgalactosamine 6-sulfatase), that is currently in Phase I/II clinical development for the treatment of MPS IVA.
Forward-Looking Statement
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the development of its product candidate PEG-PAL, and expectations related to clinical trials of PEG-PAL. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: the results of current and planned clinical trials related to PEG-PAL; the content and timing of decisions by the U.S. Food and Drug Administration and other regulatory agencies, particularly with respect to PEG-PAL, and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without restriction, the factors contained under the caption “Risk Factors” in BioMarin’s 2008 Annual Report on Form 10-K. Stockholders are urged not to dispose undue ground of trust on forward-looking statements, which speak only for example of the date hereof. BioMarin is in a state of being liable to not any obligation, and expressly disclaims any one obligation to update or alter any forward-looking statement, whether as a result of new information, future events or in other respects.
BioMarin(R), Naglazyme(R) and Kuvan(R) are registered trademarks of BioMarin Pharmaceutical Inc.
Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC.
Source: BioMarin Pharmaceutical Inc
View put drugs into notice on Kuvan.
AAPS Co-Sponsors Workshop Focusing On Modified Release Drug Products
September 23, 2009
Therapeutic equivalence to have being highlighted in event co-sponsored by the Product Quality Research Institute and the International Pharmaceutical Federation
WHO: The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific body of approximately 12,000 members employed in assiduity, academia, government and other research institutes worldwide. Founded in 1986, AAPS provides a dynamic international forum conducive to the exchange of knowledge mixed scientists to enhance their contributions to general body of mankind health. AAPS offers timely according to principles programs, on-going education, information resources, opportunities in opposition to networking, and professional development. This workshop is co-sponsored with the Product Quality Research Institute (PQRI) and International Pharmaceutical Federation (FIP).
WHAT: In union with PQRI and FIP, AAPS is pleased to present the workshop Challenges and Opportunities in Establishing Scientific and Regulatory Standards according to Assuring Therapeutic Equivalence of Modified Release Products. This two-day event will canvass some of the challenges presented by the complexity of Modified Release (MR) dosage forms. The workshop inclination consist of talks by experts from the pharmaceutical industry, academia, and the U.S. Food and Drug Administration.
WHY:This workshop aims to convene pharmaceutical scientists from academia, industry and regulatory agencies to criticise advances and regulations related to MR dosage forms, examine current and emerging issues, and identify critical paths to establishing scientific and regulatory standards for ensuring therapeutic equivalence and curative interchangeability of MR products.
WHEN: October 1-2, 2009
Sheraton Inner Harbor Hotel
Baltimore, MD, USA
Source:
Joseph Catapano
American Association of Pharmaceutical Scientists
Impax Laboratories Confirms Patent Challenge Relating To ORACEA(R) Delayed-Release Capsules, 40mg
September 22, 2009
Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by the agency of Galderma Laboratories, L.P. in relation through its ORACEA® (doxycycline) delayed-release capsules, 40 mg.
Impax filed its Abbreviated New Drug Application (”ANDA”) containing a paragraph IV certification for a generic version of ORACEA® with the U.S. Food & Drug Administration (”FDA”). Following receipt of the notice from the FDA that Impax’s ANDA had been accepted for filing, Impax notified the New Drug Application possessor and patent owners of its paragraph IV certification.
On September 18, 2009, The Research Foundation of State University of New York; New York University; Galderma Laboratories Inc.; and Galderma Laboratories, L.P. filed suit for clear infringement against Impax in the United States District Court for the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Once the ANDA is approved by dint of. FDA, Global Pharmaceuticals, Impax’session generic division, will commercialize the crops.
ORACEA® is indicated for the treatment of sole inflammatory lesions (papules and pustules) of rosacea in of age patients. According to Wolters Kluwer Health, U.S. sales of ORACEA® were approximately $104 million for the twelve-month period ending July 2009.
Source
Impax Laboratories, Inc.
DDMAC Doubles Letters This Year, Focuses on Sponsored Links
September 22, 2009
DDMAC Doubles Letters This Year, Focuses onward Sponsored Links
The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has focused on sponsored links on internet search engines this year, issuing 14 prognostic and untitled letters on account of such promotions. The division issued 33 warning and untitled letters for direct-to-consumer advertising from Jan. 1 end Sept. 15, more than half again as many because in all of calendar 2008, Thomas Abrams, DDMAC counsellor, said at the Food and Drug Law Institute’session 21st annual Advertising & Promotion Conference.
PROLOR Biotech Announces Initiation Of Phase I Clinical Trial For Its Long-Acting Growth Hormone
September 22, 2009
PROLOR Biotech, Inc. (OTC Bulletin Board: PBTH) formerly Modigene Inc., announced the initiation of a Phase I clinical trial of its long-acting human extension hormone drug solicitant hGH-CTP.
hGH-CTP is being developed to provide growth hormone deficient adults and children by dint of. the option to replace the multiple injections per week that are currently required with a once-weekly or bi-monthly injection. The initiation of the trial follows a successful safety and immunogenicity study of hGH-CTP in primates and regulatory approvals by the agency of the IRB committee of the Tel-Aviv Medical Center and the Israeli Ministry of Health.
The Phase I woe is a randomized, double-blinded, placebo-controlled, single-dose, dose-escalating study to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic properties of hGH-CTP in 24 of a sound constitution volunteers. It will exist conducted at the Early-Phase Clinical Pharmacology Unit located at the Tel-Aviv Medical Center.
“The initiation of a Phase I clinical endeavor of our long-acting hGH-CTP represents an important milestone for PROLOR,” said Dr. Avri Havron, CEO of PROLOR. “We were delighted with the results of our hGH-CTP studies in primates, which showed that hGH-CTP had an excellent half-life and biological activity and was safe at all doses tested without any one signs of immunogenicity. We are at this moment eager to obtain data adhering its bioactivity in humans.”
Dr. Havron continued, “This trial is being conducted at the Early-Phase Clinical Pharmacology Unit at the Tel-Aviv Sourasky Medical Center, a top-notch facility that has a successful footmark record of conducting more than 250 clinical studies for leading global pharmaceutical and biotech companies in a kind of clinical areas. We look forward to completing the Phase I trial in such a manner that we can move ahead with the further clinical progress to maturity of hGH-CTP.”
ABOUT hGH-CTP
hGH-CTP is PROLOR’s see preprinter long-acting version of like a human being growth hormone. hGH is used for the long-term treatment of children and adults with growth failure due to inadequate secretion of endogenous growth hormone. It is also sometimes used to counter involuntary load down deprivation and certain material manifestations of aging. Patients currently using hGH must inject the medicine betwixt two and seven times each week. In exhibition of differences, hGH-CTP is expected to require only weekly or bi-monthly injections. In 2007 the yearly report market according to hGH was estimated at $2.5 billion.
ABOUT CTP
PROLOR’s CTP technology is based on some amino acid sequence that occurs naturally in humans, the carboxyl termination peptide. When attached to a therapeutic protein, CTP extends the time that the protein is active in the material part. The potential profit of the technology has been demonstrated by Schering-Plough, what one. in 2009 announced prosperous facts from its Phase III ENGAGE trial demonstrating that women receiving a single injection of the productiveness drug FSH-CTP achieved the same pregnancy rates as women receiving seven consecutive quotidian injections of engaged in traffic FSH. This 1,509 patient trial formed the basis for a Marketing Authorization Application by Schering-Plough that is currently under review through the European Medicines Agency. PROLOR is using the like CTP technology to extend the duration of exercise of human growth hormone and other therapeutic proteins. It has an aristocratic license from Washington University in St. Louis to the CTP technology for use through every part of curative proteins omit as antidote to the four fertility hormones licensed to Schering-Plough.
ABOUT PROLOR BIOTECH
PROLOR Biotech, Inc. is a biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins and PROLOR is generally developing long-acting versions of human growth hormone, which recently entered Phase I clinical trials, and interferon beta and erythropoietin, which are in late preclinical unravelling, to the degree that well as GLP-1.
Safe Harbor Statement: This press release contains forward-looking statements, including statements regarding the results of current clinical studies and preclinical experiments and the effectiveness of PROLOR’s long-acting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements twist together risks and uncertainties that may affect PROLOR’sitting business and prospects, including the risks that PROLOR may not succeed in developing any commercial products, including any long-acting versions of human growth hormone, erythropoietin, interferon beta, GLP-1, and other products; that the long-acting products in exhibition may fall short, may not achieve the expected results or effectiveness and/or may not cause data that would favor the approval or marketing of these products toward the indications vital principle studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of somewhat grants from the OCS is problematical and is subject to management changes of the Israeli commonwealth, and that such grants may be insufficient to assist with product expansion; and other risks and uncertainties that may cause results to differ importantly from those set forth in the forward-looking statements. The increase of any products using the CTP platform technology could also be affected by a enumerate of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements instead of given conditions analyses and decision making, the striking of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third part parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLOR’s filings with the Securities and Exchange Commission.
Source: PROLOR Biotech, Inc
Micromet Reports Interim Data From Phase 1 Study Of BiTE Antibody MT110 For The Treatment Of Solid Tumors
September 22, 2009
Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, presented in the beginning mean-time data from a phasis 1 dose-escalation clinical study for BiTE antibody MT110, the in the first place T-cell engaging antibody for the manipulation of solid tumors. The interim data(1) were presented at the Multidisciplinary Congress of the European Cancer Organisation (ECCO) and 34th meeting of the European Society for Medical Oncology (ESMO) in Berlin, Germany. MT110 is designed to direct the patients’ own T cells against cancer cells that precise the epithelial cell adhesion molecule (EpCAM).
To have being reckoned, 20 patients with late-stage lung or gastrointestinal cancers have been treated with MT110. The starting dose in this phase 1 disagreeable lot escalation trial was 1 microgram for patient per day. Results from doses up to 12 micrograms in opposition to patient by means of day were reported. MT110 is administered by continuous intravenous infusion for a minimum of four weeks with the preference of adscititious treatment cycles until disease passage. No greatest tolerated drench has been reached and dose escalation is ongoing. MT110 is well tolerated through not one stage 3 or 4 clinical events related to MT110 therapy observed so far. The most usual adverse events cognate to MT110 method of treating were mild pyrexia and fatigue. Laboratory analysis of all patients revealed an early clinically asymptomatic greaten of liver enzymes that normalized after several days under continued treatment. Other laboratory abnormalities included transient lymphopenia. No cytokine release syndrome, pancreatitis or immune replication to MT110 was observed. At the dose levels pure to date, disease stabilization was seen in 7 of 18 evaluable patients in the rear of the first cycle of method of treating, and dose escalation continues.
“We are very encouraged by the tolerability of MT110 observed in this heavily pre-treated population of cancer patients and look forward to updating our results as we continue to become greater the dose,” commented Prof. Walter Fiedler from the University Hospital of Hamburg-Eppendorf, Germany, and leader investigator of the weigh.
“The interim phase 1 results and activity of MT110 at the current dose level are the kind of we expected based on our preclinical premises,” commented Christian Itin, CEO of Micromet. “We are at once looking in advance to exploring the clinical activity of MT110 at higher dose levels.”
MT110 is the assist BiTE antibody undergoing clinical investigation. Micromet also has ongoing trials despite blinatumomab (MT103), including a aspect 2 tribulation for severe lymphoblastic leukemia (ALL) and a phase 1 trial according to non-Hodgkin’session lymphoma.
(1) Fiedler, W. et al. (2009) Safety and pharmacology of the EpCAM/CD3-bispecific BiTE antibody MT110 in patients by metastatic colorectal, gastric, or lung cancer. ECCO/ESMO Meeting, Berlin, Abstract No. 1254
About BiTE Antibodies
BiTE(R) antibodies are the first T cell engaging antibodies to afford clinical benefit in cancer patients, representing a new approach to cancer therapy. While previous attempts obtain shown the potential for the carcass’s solitary abode; squalid destroying T cells to discourse on cancer, these therapies have been hampered by the cancer cells’ ability to avoid recognition by T cells. BiTE antibodies engage T cells to attack cancer cells anywhere in the body.
About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company developing novel, proprietary antibodies with respect to the treatment of cancer, inflammation and autoimmune diseases. Its product development pipeline includes fresh antibodies generated with its see preprinter BiTE(R) antibody platform, as well as conventional monoclonal antibodies. Two of Micromet’s BiTE antibodies and three of its customary antibodies are currently in clinical trials. Micromet’s preclinical product pipeline includes exclusive novel BiTE antibodies generated by its proprietary BiTE antibody platform technology. Micromet’s collaboration partners include Bayer Schering Pharma, Merck Serono, MedImmune and Nycomed.
Forward-Looking Statements
This release contains certain forward-looking statements that involve risks and uncertainties that could inducement actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the safety, competency, and intended utilization of Micromet’s BiTE antibody MT110 and other product candidates, the conduct, timing and results of hereafter clinical trials, and expectations of the future expansion of our product pipeline and collaborations. You are urged to consider statements that include the words “ongoing,” “may,” “will,” “believes,” “potential,” “expects,” “plans,” “anticipates,” “intends,” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause not merely supposed or fancied results to be unlike materially from a single one future results expressed or implied by means of any forward-looking statements include the hazard that product candidates that appeared promising in early research, preclinical studies or clinical trials do not demonstrate safety and/or efficacy in subsequent clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical apply the mind to or clinical ordeal, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further separation of preclinical or clinical trial data, the risk that we or our collaborators direction not obtain approval to market our product candidates, the risks associated with reliance on outside financing to meet forfeiting life requirements, and the risks associated by reliance on collaborators, including Bayer Schering Pharma, MedImmune, Merck Serono, TRACON and Nycomed, for the funding or escort of to a greater distance development and commercialization activities relating to our product candidates. These factors and others are more fully discussed in Micromet’s Quarterly Report on Form 10-Q instead of the financial separate into parts ended June 30, 2009, filed with the SEC on August 6, 2009, as well as other filings by the company with the SEC.
Source: Micromet, Inc.
FDA: Provide Detailed Information in Request for End-of-Phase-IIA Meeting
September 21, 2009
FDA: Provide Detailed Information in Request for End-of-Phase-IIA Meeting
FDA meetings with sponsors at the close of Phase IIA put drugs into clinical trials should help sponsors select dosing regimens for the next phase and design informative dose-response trials that incorporate the quantitative premises the sponsor has accumulated, the agency says in a final guidance. The revised guidance clarifies the type of notice the sponsor should refer with the junction desire and background package.
Biotech Innovation Could Extend Dosing Intervals, Simplify Production
September 21, 2009
Many biopharmaceuticals contain small proteins that are quickly eliminated from the body. Scientists at the Technische Universitaet Muenchen (TUM) combine such small proteins with a kindly of corpuscular balloon that swells and in this manner prolongs the half-life of the proteins in the carcass. The TUM spin-off XL-Protein GmbH has very lately started to further develop this new technology with blockbuster potential.
People who suffer from hepatitis B are often treated with the tissue hormone interferon. However, there is a problem: Interferon is a very small protein, which is filtered from the blood via the kidneys after only a at once time. For the patient this means a high-dose injection every other day to keep the effect of the substance from wearing off too early.
However, interferon stays in the body much longer when chemically coupled with a synthetic PEG (polyethylene glycol) molecule. PEG is a random perplexities long-chain polymer string that swells by adsorbing water. That way the PEG molecule becomes large sufficiency that it does not fit end the fine pores of the kidneys - the attached interferon corpse in the circulatory theory longer, and the persistent disposition need some lavement only every one to two weeks.
Using genetic engineering, TU Muenchen scientist Prof. Arne Skerra and his coworkers from the Chair of Biological Chemistry at the Center with respect to Life and Food Sciences Weihenstephan have now developed each amino acid string that tangles up similarly to PEG and also swells in the presence of supply with water. However, unlike many PEG compounds, there is no danger of this biological polymer accumulating in the body. In performance - over an extended period of unoccupied time - it is discharged or biologically craggy down. That happens as this amino acid string (polypeptide) consists of three of the 20 naturally occurring amino acids: proline, alanine and serine, or in short, PAS.
The protein substance interferon, that itself consists of amino acids, can in this manner subsist easily generated in “PASylated” form. In first trials through animals, TUM scientists established that PASyated interferon has a half-life in the offspring that is prolonged by a factor of 60, which should allow a significant extension of dosing intervals as far as concerns the time of medicinal therapy.
A more distant advantage is the simplified biotechnological production: The DNA segments carrying the information for the PAS amino acid sequence and as antidote to the interferon can absolutely be attached to each other and then, for instance, used for transforming bacteria. The bacteria then produce the PASylated interferon in one piece, thus making abundant fewer production steps necessary in compare by the chemical coupling of PEG. According to Skerra, “this will lead to a significant drop in work cost.”
In principle altogether small proteins popularly used as medication or in development in pharmaceutical companies - during the term of archetype, growth factors or functional antibody fragments - can be PASylated. Thus there could be a immense market for the modern technology. Consequently, Prof. Skerra and his team initiated the founding of a new biotech company, XL-Protein GmbH, which started its operations last spring. “Our technology has the potential to bestow coming into life to a whole new generation of blockbuster medications,” the TUM biochemist is convinced. Several of the new drugs are already at an advanced stage of preclinical development.
Source:
Patrick Regan
Technische Universitaet Muenchen
Mylan’s Matrix Receives Tentative FDA Approval Under PEPFAR For Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate Tablets
September 19, 2009
Mylan Inc. (NASDAQ: MYL) announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President’session Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.
Mylan’s product represents the first-ever fixed-dose alliance of Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate and now provides Matrix by numerous Tenofovir league product opportunities. This new deaden with narcotics adds to the Matrix portfolio of important treatments for HIV/AIDS. The product may be used during the term of either first- or second-line treatment in adults. People use second-line therapies if and at the time that they develop resistance to initially prescribed treatments.
Mylan President Heather Bresch reported: “This product represents nevertheless any other important push in our continuing war against the global prevalent of HIV/AIDS. By combining three antiretroviral (ARV) products into a once-daily dose, we can dramatically improve the quality of care for people living with HIV/AIDS in emerging markets. Lower pill burden also increases the likelihood that patients adhere to treatment. This innovation in addition adds some other affordable option to our large and rapidly growing portfolio of life-sustaining ARV products.”
The FDA’session trying approval under PEPFAR means that Matrix’s product meets all of the agency’s manufacturing temper, safety and efficacy standards. Although existing patents or exclusivity prevent its marketing in the U.S., the product resoluteness be eligible for purchase external part the U.S. in many developing countries.
Matrix’s wide scope of ARV products includes active pharmaceutical ingredients and first- and second-line completed doses. The visitors’s emphasis on producing affordable products has allowed it to drive into disfavor the average yearly record cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in developing countries who are receiving manipulation be pendent on Matrix ARV products.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in in greater numbers than 140 countries and territories. The company maintains one of the assiduity’session broadest and highest quality product portfolios supported by a robust product pipeline; operates the world’s third part largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies.
Source: Mylan Inc
Extended-release Medication
September 19, 2009
Definition: Extended-release medications have special coatings or ingredients that sway for what reason fast the drug is released from the pill into your body. This may suffer you to take certain medications only once or two times a time, instead of again often. Some extended-release medications be favored with the letters "XL" or "LA" or "XR" in their name.Also Known As: long-acting medicationExamples:
Detrol LA (tolterodine) is a medication used to treat overactive bladder.
Effexor XR (venlafaxine) is a medication used to treat blues.
Toprol XL (metoprolol) is a medication used to treat high blood embarrassment.
More Information from Dr. Mike
- Ask Dr. Mike About Your Medications
- Find Your Drug Using Drugs A to Z
- Establish parameters for the application of oversight groups, so that sponsors have a clear understanding of when each type of oversight group is needed as antidote to a clinical study.
- Provide practical leadership adhering how to grow appropriate guidelines for oversight group implementation, so that sponsors are familiar through best practice for inattention group compiling, workflow, dataflow, data capture and data analysis.
- Present effective models for use of multiple oversight groups on a single trial, so that sponsors gain thorough knowledge into the relationships between their CECs, DMCs and Steering Committees. This expression of the conference decision address the areas in what one. oversight group communications and facts exchanges most many times intersect. It will also embrace the areas in which appropriate boundaries and firewalls be bound to be established between oversight groups.
- Address best practices to nutriment effective interactions between sponsors and their oversight groups, so that apposite communications and data exchanges be disclosed, further the independent nature of the fault groups is preserved.
Forest Laboratories Presents Analysis Of Two Positive Pivotal Phase III Studies Of Ceftaroline For The Treatment Of Community-Acquired Pneumonia (CAP)
September 19, 2009
Forest Laboratories, Inc (NYSE: FRX) presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco starting anew data from a complete analysis of FOCUS 1 and FOCUS 2, two global multicenter Phase III studies of ceftaroline for the treatment of community-acquired pneumonia (CAP) in hospitalized patients. Detailed analyses from the previously reported top-line data of the two pivotal trials demonstrated that ceftaroline administered intravenously met the principal endpoint of non-inferiority in patients with moderate to severe CAP requiring hospitalization.1 Ceftaroline therapy was also in most cases well tolerated, with an adverse issue side view homogeneous to ceftriaxone.
CAP is a serious illness and common cause of subjection to death and morbidity. In the U.S. each estimated 5.6 million cases of CAP occur year by year, resulting in an mean proportion of 4.5 the great body of the people visits to physicians’ offices and as many as 1.1 million hospitalizations.2,3,4
Integrated Results
The randomized, double-blind, multicenter Phase III studies compared clinical outcomes following usage with ceftaroline versus ceftriaxone in hospitalized adult patients with moderate to severe CAP.
The combined results of FOCUS 1 and FOCUS 2 demonstrated a clinical cure berate of 84.3% for ceftaroline and 77.7% for ceftriaxone in the integrated clinically evaluable (CE) constant enumerate of men. The overall microbiological rejoinder rate in the microbiologically evaluable (ME) population was 87% for ceftaroline and 81% with regard to ceftriaxone, and in the microbiological modified intent-to-treat (MITT) population it was 84.8% for ceftaroline and 80.4% for ceftriaxone.
“The robust data that own emerged from FOCUS 1 and 2 demonstrate that ceftaroline is a very promising new cephalosporin for the management of serious pneumonia in hospitalized patients,” said Dirk Thye, MD, President of Cerexa, the wholly owned anti-infectives subsidiary of Forest Laboratories, Inc. “The continuing medical need to deal with emerging resistance to existing therapeutic options is clear and pertinacious. These results, along with our prior indisputable results in complicated pelt and skin structure infections (cSSSI)5, confirm that ceftaroline has unique properties allowing it to address this medicinal indigence. We intend to submit our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) beneficial to cSSSI and CAP around the end of this calendar year.”
In etc. to these couple pivotal studies for CAP, data on the microbiology of ceftaroline is being presented at ICAAC, demonstrating its bactericidal nimbleness in vitro and in animals in countervail to a broad range of pathogens including those commonly implicated in the two cSSSI and CAP, as well as MRSA and multi-drug resistant Streptococcus pneumoniae (MDRSP).
Posters
— Snydman DR, Jacobus NV, et al. In Vitro Activity of Ceftaroline vs a Broad Spectrum of Recent Clinical Anaerobic Isolates. Poster #903-M-060.6
— Citron DM, Goldstein EJC, et al. In Vitro Activity of Ceftaroline Against Anaerobic Bacteria. Poster #903-M-058.7
— Farrell DJ, Patel SN, et al. Activity of Ceftaroline (CPT) Against Recent Streptococcus pneumoniae (SP) Isolates From the Canadian Bacterial Surveillance Network (CBSN). Poster #903-M-067. 8
— Jacobs MR, Bajaksouzilan S, et al. Activity of Ceftaroline Against Emerging Serotypes of Streptococcus pneumoniae. Poster #903-M-069. 9
— Jones RN, Sader HS, et al. Antimicrobial Activity of Ceftaroline Tested against streptococci from United States (USA) and European (EU) Medical Centers: Results from the Ceftaroline Longitudinal Assessment of Spectrum and Susceptibility (CLASS) Program. Poster #0903-M-035.10
— Vidaillac C. Newton K, et al. Evaluation of Oxacillin, Daptomycin, and Ceftaroline Activity Against Clinical Vancomycin Heterovariant Methicillin-Resistant Staphylococcus aureus (MRSA). Poster #903-M-074.11
— Jacqueline C, Amador G, et al. Activity of Ceftaroline (CPT) vs Daptomycin (DAP), and Tigecycline (TGC) Against Methicillin-Susceptible, Methicillin-Resistant, and Glycopeptide-Intermediate Staphylococcus aureus: An Experimental Rabbit Endocarditis Study. Poster #903-M-042.12
— Sader HS, Mendes RE, et al. Antimicrobial Activity of Ceftaroline Tested Against Streptococci From United States (USA) and European (EU) Medical Centers: Results from the Ceftaroline Longitudinal Assessment of Spectrum and Susceptibility (CLASS) Program. Poster #0903-M-035.13
— Kosowska-Shick K, McGhee P, Appelbaum P. Affinity of Ceftaroline and Caparator b-lactams to Penicillin-Binding Proteins (PBPs) from Staphylococcus aureus. Poster #903-M-041.14
About Ceftaroline and Ceftaroline / NXL104
Ceftaroline is a novel, bactericidal, injectable, broad-spectrum cephalosporin being developed as a therapeutic performer in opposition to the method of treating of cSSSI and CAP that embrace gram-positive pathogens such like methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant S. pneumoniae (MDRSP), as fortunate as inferior gram-negative organisms. Ceftaroline has demonstrated antibacterial activity in vitro against vancomycin-resistant S. aureus (VRSA) and linezolid-resistant S. aureus. Ceftaroline is a portion of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. In clinical trials, ceftaroline has been generally well tolerated by an adverse event profile consistent with the cephalosporin rank of antibiotics. Forest obtained the worldwide rights (excluding Japan, where Takeda Pharmaceuticals holds rights) to ceftaroline when it acquired Cerexa, Inc, a secretly held biopharmaceutical company, in 2007. In August 2009, Forest Laboratories and AstraZeneca (NYSE:AZN) entered into a categorical collaboration agreement to co-develop and commercialize ceftaroline in entirely markets outside the U.S., Canada and Japan.
Forest is likewise developing a cabal outcome consisting of ceftaroline and NXL104, a novel beta-lactamase inhibitor. The combination of NXL104 through ceftaroline enhances the in vitro antibacterial activity of ceftaroline against extended-spectrum beta-lactamase-producing (ESBL) gram-negative bacteria that are normally resistant to currently available broad-spectrum cephalosporins.
About CAP Requiring Hospitalization
In 2006, pneumonia, side by side with influenza, was the eighth leading cause of death in the U.S. and the number one aim of death in those over age 65.15,16The cost of care according to patients with CAP in the U.S. has been estimated to be over $10 billion annually.17
The primary usage for CAP is antibiotics14 and the rates of resistance to many commonly used antibiotics is increasing.18 S. pneumoniae accounts for 60% to 70% of all bacterial CAP cases and data have shown that, overall, pneumococcal strains had a 28% intermediate resistance rate and a 16% high-level resistance rate.19 With increasing rates of inflammation of the lungs caused by MRSA and the high rates of rebuff to indifferent antibiotics, management options are becoming more limited.20
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical crew with a long trace record of construction partnerships and developing and marketing products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in whole stages of increase and across a wide range of therapeutic areas.
Except for the historical knowledge contained in this respect, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inwrap a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the hazard factors listed from time to time in Forest Laboratories’ Annual Report upon Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
References
(1). Eckberg P, Friedland HD, et al. FOCUS 1 and 2: Randomized, Double-blinded, Multicenter Phase 3 Trials of the Efficacy and Safety of Ceftaroline (CPT) vs. Ceftriaxone (CRO) in Community-acquired pneumonia (CAP). Presentation L1-345a. Presented at ICAAC 2009.
(2). Neiderman MS, McCombs JI, Inger AN, Kumar A, Popovian R. The cost of treating community-acquired pneumony in the United States. JAMA. 1996; 275: 189-193.
(3). Garibaldi RA. Epidemiology of community-acquired respiratory tract infections in adults: incidents, etiology and impact. Am J Med. 1985:78:32S-37S.
(4). Centers for Disease Control and Prevention. Premature deaths, monthly humanity and monthly physicians contacts United States. MMWR Morb Mortal Wkly Rep. 1997; 46:556.
(5). Corey R, Wilcox M, Talbot GH, et al. CANVAS-1: Randomized, Double-blinded, Phase 3 Study (P903-06) of the Efficacy and Safety of Ceftaroline vs. Vancomycin plus Aztreonam in Complicated Skin and Skin Structure Infections (cSSSI). Presented at ICAAC / IDSA 2008.
(6). Snydman DR, Jacobus NV, et al. In Vitro Activity of Ceftaroline vs a Broad Spectrum of Recent Clinical Anaerobic Isolates. Poster #903-M-060. Presented at ICAAC 2009.
(7). Citron DM, Goldstein EJC, et al. In Vitro Activity of Ceftaroline Against Anaerobic Bacteria. Poster #903-M-058. Presented at ICAAC 2009.
(8). Farrell DJ, Patel SN, et al. Activity of Ceftaroline (CPT) Against Recent Streptococcus pneumoniae (SP) Isolates From the Canadian Bacterial Surveillance Network (CBSN). Poster #903-M-067. Presented at ICAAC 2009.
(9) Jacobs MR, Bajaksouzilan S, et al. Activity of Ceftaroline Against Emerging Serotypes of Streptococcus pneumoniae. Poster #903-M-069. Presented at ICAAC 2009.
(10) Jones RN, Sader HS, et al. Antimicrobial Activity of Ceftaroline Tested against streptococci from United States (USA) and European (EU) Medical Centers: Results from the Ceftaroline Longitudinal Assessment of Spectrum and Susceptibility (CLASS) Program. Poster #0903-M-035 Presented at ICAAC 2009.
(11) Vidaillac C. Newton K, et al. Evaluation of Oxacillin, Daptomycin, and Ceftaroline Activity Against Clinical Vancomycin Heterovariant Methicillin-Resistant Staphylococcus aureus (MRSA). Poster #903-M-074. Presented at ICAAC 2009.
(12) Jacqueline C, Amador G, et al. Activity of Ceftaroline (CPT) vs Daptomycin (DAP), and Tigecycline (TGC) Against Methicillin-Susceptible, Methicillin-Resistant, and Glycopeptide-Intermediate Staphylococcus aureus: An Experimental Rabbit Endocarditis Study. Poster #903-M-042. Presented at ICAAC 2009.
(13) Sader HS, Mendes RE, et al. Antimicrobial Activity of Ceftaroline Tested Against Streptococci From United States (USA) and European (EU) Medical Centers: Results from the Ceftaroline Longitudinal Assessment of Spectrum and Susceptibility (CLASS) Program. Poster #0903-M-035. Presented at ICAAC 2009.
(14) Kosowska-Shick K, McGhee P, Appelbaum P. Affinity of Ceftaroline and Caparator b-lactams to Penicillin-Binding Proteins (PBPs) from Staphylococcus aureus. Poster #903-M-041 Presented at ICAAC 2009.
(15) Centers for Disease Control and Prevention. National Center for Health Statistics. Deaths: Preliminary Data for 2005. September 2007.
(16). Heron M, Hoyert D, Murphy S. National Vital Statistics Reports. Deaths: Final Data for 2006. 2009 April; 57:14.
(17). Lave, JR, Lin CJ, Fine MJ, et al. The require to be paid of treating patients with community-acquired pneumonia. Semin Respir Crit Care Med. 1999;20(3):189-97.
(18). Official Statement of the American Thoracic Society. Guidelines for the Management of Adults with Community-acquired Pneumonia. Am J Repir Cric Care Med. 2001;163:1730-1754.
(19). Lutfiyya MN, Henley E, Chang L. Diagnosis and Treatment of Community-Acquired Pneumonia. Am Fam Physician. 2006 Feb 1;73(3):442-50.
(20). Mandell L. Wunderink A, Anzueto, J, et al. Infectious Diseases Society of America / America Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44:(Suppl. 2)S27-S72.
Source: Forest Laboratories
Abbott Expands Use Of Sustainable Packaging As Part Of Global Environmental Efforts
September 18, 2009
Abbott today reported more remote progress in encounter its goal of a 5 percent reduction in the amount of packaging used in its key products by 2013, part of a multi-faceted effort to minimize its impact on the environment. To bring to pass this bound, the society has launched, or is in the projection of launching, greater amount of than 40 sustainable packaging initiatives across its nutrition, pharmaceutical and medical products businesses. The initiatives are driven by new standards and guidelines developed by Abbott that animate increased use of lighter and sustainable materials in package delineate.
“Abbott’s sustainable packaging initiatives enjoin reduce our environmental footprint through not so much waste in landfills, to a greater degree responsible grove management and fewer emissions. At the similar time, it lowers cost, and, in some cases, reduces shelf space for our customers,” said John Landgraf, senior vice president, Pharmaceuticals, Manufacturing and Supply, Abbott. “Throughout the earth, consumers increasingly expect the companies they do avocation with to be environmentally responsible citizens and Abbott is rising to that challenge.”
Abbott partners with a number of industry and unconventional groups in the area of sustainable packaging, such as the Sustainable Packaging Coalition. Abbott moreover is working by suppliers who have achieved or are pursuing certification, with respected sustainability organizations, such as the Program for the Endorsement of Forest Certification, the Forest Stewardship Council and the Sustainable Forestry Initiative. In addition, Abbott recently announced sponsorship of the newly created Michigan State University’s Center for Packaging Innovation and Sustainability, which provides a tribunal to build a bridge over academic investigation through Abbott’sitting real-world application expertise.
“Abbott has been actively moving to benchmark and measure make progress in making its packaging more sustainable,” said Anne Johnson, director, Sustainable Packaging Coalition, a project of GreenBlue, a nonprofit sustainability literary that works with the private sector to enable the positive redesign of industrial systems. “Given the momentous challenges of packaging for health care products, it is impressive to see that they have place systems in place in recent years that have resulted in tangible results. We look forward to continuing our collaboration with them and other industry leaders to advance in successive packaging systems that promote household and environmental health.”
In etc., Abbott works with major retail customers, sharing information on packaging reductions the company has achieved in its consumer products. The company also screens its suppliers, holding them to stringent packaging requirements. In 2008, the company created an internal packaging propose to one’s self guideline writing to render less difficult improved sustainable packaging decisions throughout the design and development phase of packaging.
“Our sustainable packaging placing in charge is the latest example of Abbott’session legacy of doing its part to safeguard the environment,” explained Donald Patton, Jr., senior vice president, U.S. Nutrition, Abbott. “Across the company, Abbott is transitioning to packaging that performs its essential functions while using less stuff and more environmentally-friendly components.”
Abbott is working toward delivery on this commitment through a variety of strategies, including embracing the four R’s (cut short, recycle, renew and re-use). Since 2007, Abbott has eliminated each estimated 2.88 very great number pounds of packaging on an annualized basis through reduction initiatives attached a few select products, the equivalent of preventing 15,000 pounds of polystyrene foam from going into landfills. In addition, Abbott reduced the amount of plastic used in infant formula containers by 15 percent in 2008. Some of Abbott’s major sustainable packaging initiatives include:
- Abbott Nutrition reduced the amount of plastic in its eight ounce re-closable bottles by 8.3 percent. Through better design, the company cut polypropylene plastic usage through 2.7 the multitude pounds annually. The reduced-weight bottles also will forbear save 436,000 gallons of gasoline used for transportation per year.
- Abbott recently implemented a pilot program for shipments of more physician samples that prescribe cooling. During the pilot, Abbott is exploring ways to have effect this environmentally-friendly alternative deserving comparison in require to be paid to current packaging. The reusable box - which replaces a larger, single-use box - is smaller, made of reusable, recyclable and 100 percent organic-based materials, and can subsist used greater amount of than 100 general condition of affairs.
These are just a coupling of examples of the more than 40 sustainable packaging projects even now introduced or in the process of being launched across Abbott’sitting health care businesses. The company’s sustainable packaging team continues to attain to new ways to reduce Abbott’s environmental footprint from one side innovative design and the application of the latest packaging technology.
Safeguarding the environment is an important part of Abbott’sitting mission to improve people’s health and the company’sitting efforts to be a commander in global citizenship. In addition to expanded application of sustainable packaging, Abbott has identified reductions in conservatory gas emissions, water conservation and increased exercise of cleaner and renewable energy as environmental priorities. The company has set measurable goals in one and the other of these areas to track its progress. All of Abbott’s various soundness care businesses are examining their manufacturing processes and necessarily, as well as their result packaging, to make known environmentally friendly and sustainable approaches to help the company meet or exceed these goals.
Abbott was recently named to the Dow Jones Sustainability World Index and Sustainability North America Index for the fifth consecutive year, and was one of just two U.S.-based pharmaceutical companies listed on the couple exponents. The Dow Jones Sustainability World Index ranks Abbott among the top 300 of the universe’sitting largest 2,500 companies, based put on an assessment of economic, familiar and environmental performance.
Source
Abbott Laboratories
Abbott Wins Top Honor In Wall Street Journal Technology Innovation Awards
September 18, 2009
Abbott announced it has been named the overall Gold winner of the 2009 Wall Street Journal Technology Innovation Awards for its Ibis T5000 Biosensor regularity, what one. is designed to detect and characterize a gross range of infectious agents in a given sample, including viruses, bacteria and fungi.
“Abbott is dedicated to pursuing novelty to find meaningful solutions that improve lives,” said Stafford O’Kelly, head of Abbott’s molecular diagnostics business. “This technology represents scientific innovation at its highly best, and Abbott is honored to receive this serious award.”
Abbott’sitting Ibis system (now marketed under the PLEX-ID employment name) was singled out for the top honor, in part, because it promises to alert freedom from disease officials to new disease strains, and may moreover guard in anticipation of bioterrorism and enable hospitals to identify antibiotic-resistant bacteria in its environment.
The Wall Street Journal reports that inasmuch as the first system was completed in 2005, the technology has “been deployed in 20 sites round the U.S., including the Centers for Disease Control. This spring, the device helped the Naval Health Research Center in San Diego to identify the first two cases of the H1N1 swine flu in the U.S.”
The PLEX-ID is a high-throughput technology based in succession a combination of corpuscular technologies, including polymerase chain reaction (PCR) and congeries spectrometry analysis. The system is designed to address a signifying unmet need by providing touchstone results in six to seven hours instead of three or besides days as required with current culturing methods.
PLEX-ID is generally intended for research use only and not for use in diagnostic procedures. It is clever of identifying to all intents and purposes quite bacteria, viruses and fungi, and be able to provide information about drug resistance, poisonousness and strain type of these agents. Commercial applications for the system include epidemiologic oversight, monitoring of pandemic diseases, identification of emerging or previously unknown agents, forensic characterization of human samples, identification of sources of hospital-associated infections. Abbott is currently developing the system for human catching ail diagnostics.
Source
Abbott Laboratories
FDA: 13 PML Cases Confirmed in Tysabri Patients
September 18, 2009
FDA: 13 PML Cases Confirmed in Tysabri Patients
The FDA says in that place have been 13 confirmed cases of progressive multifocal leukoencephalopathy (PML) in patients taking Biogen Idec and Elan Pharmaceuticals’ Tysabri for multiple sclerosis (MS) in the past three years. Biogen and Elan voluntarily suspended the marketing of Tysabri (natalizumab) in 2005 because of two PML brain infections in patients taking the mix with drugs. The drug was reintroduced in July 2006 beneath a restricted distribution program, and from that point till Sept. 8, 13 PML cases, four of them in the U.S., were confirmed in patients taking the put drugs into as monotherapy in the place of MS, the FDA says in a statement.
Drug Discovery Process More Accurate, Less Expensive Using Novel Mass Spectrometry Application
September 18, 2009
Cancer and cell biology experts at the University of Cincinnati (UC) have developed a new mass spectrometry-based tool they say provides more precise, cost-effective data collection for drug discovery efforts.
Preliminary studies have shown that the new totality spectrometry tool - known in the same proportion that MALDI-QqQMS (matrix-assisted laser desorption ionization-triple fourfold size spectrometer) - provides a more dignified substance of measuring the enzyme reactions critical to drug discovery at speeds worthy of comparison to currently available high-throughput screening systems at significantly depress costs.
“If introduced broadly, the recent generation mass spectrometry-based method we are proposing could significantly reduce the cost of running drug compound screening assays at the same time that too sparing remedy development teams substantial time by means of improving the accuracy of data collected,” explains Ken Greis, PhD, ally. professor and director of proteomics for the UC College of Medicine’s cancer and cell biology department.
Greis and his colleague Rakesh Rathore, PhD, give out their findings online ahead of print Sept. 17, 2009, in the scientific diary Rapid Communications in Mass Spectrometry.
In the drug discovery field, scientists employment the kind of is known in the same proportion that a “high-throughput screening system” to rapidly run thousands to millions of tests to screen for inhibitors of molecular targets that could be good in pharmaceutical drug development and in furthering of knowledge of the overall biological mechanisms in the rear a particular disease.
Typical assays for enzyme screening are fluorescence and chemiluminescence-based systems. To make those assays universal, vendors have developed standard kits using specialized - and costly - reagents to identify changes in the fluorescent or chemiluminescent signals.
“There are a couple of problems with the circulating approach: For starters, it’sitting any imperfect method that generates many false-positive “hits” and for exactly diligence, you be favored with to follow up on all inhibitors identified, what one. results in a lot of time and money wasted on false leads,” says Greis.
“Reagents are very costly repeatedly ranging betwixt 50 cents to $1 per sample. That adds up very immediately when you’re screening against a million-compound library,” adds Rathore, a postdoctoral fellow in Greis’ laboratory.
Greis and Rathore have developed a practice high-throughput screening method using a generalized platform. Unlike the commercially available systems that analyze byproducts and coupled reactions, their system directly measures and quantifies the substrate and the end produce of the recoil.
They say using mass spectrometry to measure the mass and quantity of the product gives researchers a dispose measure of the assay and more trustworthy compounds to scrutinize, eliminating the chances for molecular interference common with chemiluminescence and fluorescence-based systems.
“Analytically, our mass spectrometry-based application provides superior premises and in addition eliminates the issue of producing northerly numbers of false results, saving a tremendous amount of time chasing from a thin to a dense state bad leads on unsalable article targets. And on this account that we are using these non-tagged reagents, it no other than costs us 3 to 5 cents per pattern to run these assays, which is a very large require to be paid savings,” adds Greis. “That can contemplate the schism between $50,000 and $1 the great body of the people in reagent costs for a single screening project.”
The approach developed by the UC group also holds appeal in that it has multiplexing capabilities - making it in posse to, measure inhibitors for sum of two units or more enzymes with one live through through the compound repository. Typical assays start with one mark enzyme and that is tested against an entire compound repository to look for inhibitors. Once inhibitors are identified, researchers must then follow up on each one to know if it has any validity as a drug target.
“Now instead of doing a million-dollar campaign that takes a month to run and then another million-dollar campaign that takes another month to run, we can do the pair at the same time while still avoiding the false-positives and false-negatives usual through popularly available methods,” says Greis. “This is the same of those disruptive technologies that could completely change the regular course people do this type of screening work.”
The UC team is working on identifying funding to transition this mass spectrometry-based technology into a fully automated system for relating to traffic use.
In addition to Greis and Rathore, coauthors of the study take in William Siebel, PhD, of UC’s Drug Discovery Center and Jay Corr, PhD and Daniel Lebre, PhD, of MDS Analytical Technologies. Rathore’sitting fellowship is funded by MDS Analytical Technologies.
Source:
Amanda Harper
University of Cincinnati Academic Health Center
Conference To Offer Important Insights And Information On Sponsor Relationships With Clinical Oversight Group, Oct. 14-15, 2009, Loews, Philadelphia
September 18, 2009
In replication to the ostentatious demand during the term of guide information and superlatively good practices for working through clinical oversight groups, ExL proudly presents the Clinical Oversight Groups conference to elect place upon the body October 14-15, 2009 in Loews, Philadelphia, Pennsylvania. Sponsors a little while ago have the opportunity to learn from industry professionals on how to improve trial managements and decision making through prosperous interactions with oversight groups.
This groundbreaking event provides clinical chagrin sponsors with adapted to practice information about the purpose, role and responsibilities of each of these types of oversight groups. The overall objectives of the meeting for consultation are to:
Background:
Clinical oversight groups are each important part of a sponsor’s management generalship for multiple aspects of a wide number of clinical studies. Implementation of expert oversight groups, whose members are independent of the trial sponsor, ensures any objective survey of trial given conditions for a number of purposes. Clinical Endpoint Committees (CECs) review and adjudicate study endpoints and provide standardized results that are utilized for statistical analyses of efficacy and safety outcomes. Data Monitoring Committees (DMCs) conduct recurring go over again of accumulating trial premises to admonisher patient safety and continually evaluate the emerging Benefit-Risk balance data that is produced as a result of protocol implementation. Steering Committees collaborate with the surety across the continuum of dolor management, from protocol development to error of dolor manner of life to signification of apply the mind to results. Clinical oversight groups bring value by helping sponsors design and conduct trials that are ethical and that produce valid and not improbable results.
Having full knowledge and understanding of CEC, DMC and Steering Committee processes enables sponsors to successfully implement oversight groups in appropriate settings, resulting in sound and effective judgment formation for on-going clinical projects.
Conference Sponsors:
The event is sponsored by Axio and Quintiles, and supported by the Society for Clinical Data Management (SCDM) and the Association of Clinical Research Professionals (ACRP).
Additional Information:
The Clinical Oversight Groups’ full program is available for review here.
For registry information, visit the conference website or email: register@exlpharma.com. Please reference priority code P434PR when registering or inquiring about the event.
Take advantage of the particular group discounts. Register three people and receive 15% off of each registry. Register four people and receive 25% off of each registration. Please note that all three must register at the same lifetime.
About ExL Pharma:
ExL Pharma is a leader in developing innovative, educational events that serve the healthcare community and similar professionals. Behind a variant conference portfolio, each experienced team conducts broad market research and targeted outreach. The results translate into innovative, high-quality conference events designed to exceed the dynamic informational needs of the healthcare community.
Source:
Jasmaine John
Marketing Director
ExL Pharma
555 8th Avenue, Suite.310
New York, NY 10018
Largest Drugmakers Would Bear the Brunt of New Fees in Baucus Proposal
September 17, 2009
Largest Drugmakers Would Bear the Brunt of New Fees in Baucus Proposal
Drugmakers marketing products for the elderly probably will face the highest recurring with the year fees under a $2.3 billion annual program designed to withstand pay for Sen. Max Baucus’ (D-Mont.) healthcare examine legislation, Jack Calfee, an American Enterprise Institute economist who studies the drug industry and the FDA, before-mentioned, adding that drugmakers could offset the effect by raising prices. The America’s Healthy Future Act, released Wednesday upon Capitol Hill, would give the Treasury secretary the authority to estimate anniversary fees for drugmakers based on the amount of sales of branded recipe drugs sold to Medicare, Medicaid, Veterans Health Administration and Tricare.
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